With the dawn of modern technical advances comes the ability to duplicate, change, alter and distribute just about anything. The Law enforcement organizations have called counterfeiting the crime of the 21st century. Product counterfeiting is a serious and growing threat. Measures to defend against counterfeiters are being taken by many corporations, but they have not developed comprehensive, systematic, and cost-effective solutions to preventing counterfeiting.
Due to advancing counterfeiting techniques, traditional anti-counterfeit technologies are becoming obsolete. Additionally, governments and corporations that have invested a great deal of resources in fighting counterfeiting have experienced little success. Furthermore, law enforcement agencies that are burdened with efforts to combat violent crimes have insufficient resources to fight the “victimless” counterfeiting crime. For example, a company owning a famous brand name may have spent years developing and promoting the superior qualities of its goods to establish good will of the public and may be unable to stop a counterfeiter or a newcomer company product inferior quality goods.
Counterfeiting also extends to medical and pharmaceutical areas where counterfeiting can pose a serious threat and danger to public health. For example, goods such as oral pharmaceuticals encapsulated in tablets may be easily counterfeited. Counterfeiting of this nature is particular adverse to the interests of original manufacturers of the drugs because this negatively impacts the sales of their products, but this also allows the wide and unsafe dissemination of dubious drugs. Consequently, both the public and the manufacturer face serious health and medical consequences and liability vis a vis the public because consumers may be sold counterfeit gray goods such as counterfeit drugs unbeknownst to them.
For example, one such difficulty lies in determining the origin of the drugs, particularly if the drugs themselves are not marked in such as way as to unequivocally determine their authenticity. This has often been the case with tablets. A problem is that although a package containing tablets may include a source designation code and other identifying brand or laboratory indicia, the tablet itself is not assigned such a code and may therefore be easily repackaged to hide its channel of distribution. Further, the absence of such a code or marking fails to assist in the identification of the distributor licensee that was responsible. Often tablet containers and packaging are properly marked and sealed so that the manufacturing source can be identified by some ID number. Since the container is sealed, one would expect that the tablets inside the container, for example, match the lot number on the container. Regrettably, as the cost of medication rises, the temptation grows for domestic and international manufacturers or suppliers to substitute some or all of the tablets of the container with a cheaper generic version or worse, inferior quality or counterfeit drugs, then seal the container, and pass it off as containing the tablets from the original name brand. It is likely that the consumer will not suspect the switch, although some may notice that the medication is less effective than expected. Regardless, the business profits handsomely. The manufacturer of the brand name product, however, in effect loses a sale and, worse, loses some of its good will as the consumer wrongfully blames the brand name manufacturer for the poor quality over which the manufacturer had no control. If the consumer suffers medically from the switched medication, the integrity of the brand name is damaged, not to mention the serious legal and product liability the manufacturer faces. In addition, the consumer does not get the brand name product for which he or she paid a premium. One reason this problem arises is because the consumer has no way of checking whether the tablets in the container are the proper tablets made by the labeled manufacturer.
Thus, many approaches have been proposed for authenticating drugs and solid pharmaceutical goods, but none of these have proven entirely satisfactory. In particular, such proposed approaches do not provide an effective foolproof anti-piracy deterrent because many can be tampered with. For example, applying a bar code on the surface of a tablet can be easily tampered with. Such micro bar codes and administration of bar indicia on tablets, normal printing procedures such as roller rotation methods, ink-jet printing of tablets, are well known but not foolproof against forgeries and can be labor intensive to implement due to different porosity of pharmaceutical drugs, different quality of active ingredients of a tablet, the different thickness, absorption and smoothness of the tablets, the non-planar small surface of the various types of different tablets, etc. This means that all these factors affect and influence the quality of the authentication and marking.
Therefore, these previously known approaches do not provide adequate authentication and can often be defeated by clever tampering, copying, spoofing, or other advanced counterfeiting techniques. With all these facts in mind, the realization of a simple method for labeling or printing pharmaceutical drugs using high quality standards and a simple method for verification seems to be out of reach.